Flexicare Medical (Dongguan) Ltd.
DONGGUAN CITY Guangdong, CN
FLEXICARE MEDICAL (DONGGUAN) LTD. appears in FDA device records in DONGGUAN CITY Guangdong, CN. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006061749 | 3006061749 | FLEXICARE MEDICAL (DONGGUAN) LTD. | No. B-15 XICHENG INDUSTRIAL ZONE, DONGGUAN CITY Guangdong 523460 CN | 2026 | and 38 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BTQAirway, Nasopharyngeal
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BTCBag, Reservoir
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- CATCannula, Nasal, Oxygen
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- JOLCatheter And Tip, Suction
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- HXDClamp
- HFXClamp, Circumcision
- BXJClip, Nose
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- CBHDevice, Fixation, Tracheal Tube
- BYHDrain, Tee (Water Trap)
- MNKEndoscopic Bite Block
- IONExerciser, Non-Measuring
- CAHFilter, Bacterial, Breathing-Circuit
- HTDForceps
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- NVPHolding Chambers, Direct Patient Interface
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- CCWLaryngoscope, Rigid
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- BYFMask, Oxygen, Low Concentration, Venturi
- KGBMask, Oxygen, Non-Rebreathing
- KHAMask, Scavenging
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- KBWScrew, Oral
- BZOSet, Tubing And Support, Ventilator (W Harness)
- FOXStand, Infusion
- BTKStrap, Head, Gas Mask
- BSRStylet, Tracheal Tube
- NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- BTRTube, Tracheal (W/Wo Connector)
- GAZTubing, Noninvasive
- BYXTubing, Pressure And Accessories
- JRLUnit, Filter, Membrane
- EXRUrinometer, Mechanical
- BTMVentilator, Emergency, Manual (Resuscitator)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2187-2025 | BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U | Laryngoscope handles may not illuminate as intended. | Class I | Open, Classified | |
| Z-2186-2025 | BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U | Laryngoscope handles may not illuminate as intended. | Class I | Open, Classified | |
| Z-2185-2025 | Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U | Laryngoscope handles may not illuminate as intended. | Class I | Open, Classified | |
| Z-2184-2025 | BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U | Laryngoscope handles may not illuminate as intended. | Class I | Open, Classified | |
| Z-2183-2025 | BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2) | Laryngoscope handles may not illuminate as intended. | Class I | Open, Classified | |
| Z-2182-2025 | BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3), | Laryngoscope handles may not illuminate as intended. | Class I | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain